An adaptive dose-ranging trial of telmisartan in HIV patients
Delivering complex and innovative trials
Summary
The clinical research landscape is changing and clinical trials are evolving to find new, faster and more efficient ways to bring new treatments to patients.
The NIHR has been supporting the delivery of novel, complex and innovative clinical trials over the last decade. Find out how we can support you to plan, set up and deliver your trial or study to time and target in the UK.
Complex clinical trial designs (methodologies) and innovative approaches to recruitment and delivery have the potential to improve the speed and efficiency of clinical trials, shorten drug development timelines and, ultimately, bring new treatments to patients faster. Developments in science and technology also mean that innovative clinical trials are needed to assess new medicines in different (often smaller, more specific) patient populations.
The NIHR is responding to this evolution and on this page you can discover how we are supporting the next generation of clinical trials.
Through case study content you will find out how we are advocating the adoption of the adaptive trial model, helping to realise the value of registry-facilitated research, and promoting the benefits of the platform approach, to name just a few.
Complex and innovative trial designs
The phrase ‘complex and innovative trial design’ includes, but extends further than the trial methodology or design. The complexity may also exist in the set-up, recruitment, delivery or the statistical analysis and mathematics which underpin the trial. The term should be used in its broadest sense, and not be limited to specific trial designs.
Any trial design that differs from the standard randomised controlled trial (RCT) design and delivers results more efficiently, reduces the study timeline, and maximises the knowledge gained could be described as novel or innovative.
Common examples of methodologies that are considered complex and/or innovative include:
- Adaptive (umbrella, basket, adaptive, platform, dose-ranging)
- Targeted or stratified
- Real-world
- Bayesian
The following case studies illustrate how the NIHR has been supporting some of these approaches:
- FOCUS4: Foundations for fighting COVID-19 - Learn how forward-thinking approaches to cancer clinical trials from the last decade have featured in the UK’s fight against COVID-19
- National Lung Matrix Trial: Laying the groundwork for combatting COVID-19 - Learn how our history of cutting-edge cancer research underpinned the UK’s COVID-19 research response
- TAILoR trial: Adopting an adaptive approach to help HIV patients on antiretroviral therapy (cART)
- Using an adaptive model to trial a new treatment for rare kidney disease
- REMAP-CAP tests treatments for COVID-19
- The UK's flagship COVID-19 treatment trial - the RECOVERY trial
Innovative delivery
When we talk about ‘innovative delivery’ we are focusing on the set-up and the delivery of the trial, as opposed to the design. The design may be simple or standard, but the way it is delivered may be more streamlined, efficient, quicker or more patient-friendly than what has been done before. The term should be used in its broadest sense for all approaches that present an innovative solution to trial delivery. For example, this includes research that is conducted using:
- electronic patient records and data linkages
- research registries and biorepositories
- digital tools for electronic patient reported outcomes (ePROMs)
- streamlining processes across sites
- risk adaptation (e.g. virtual monitoring, proportionate Source Data Verification SDV)
- proportionate consent (e.g. cluster randomisation, emergency settings)
- virtual, decentralised and/or siteless trials
- health services research and public health research
The list is not exhaustive and other approaches, such as patient-led trials, also fall into this category.
The following case studies illustrate how the NIHR has been supporting some of these approaches.
- RELIEVE IBS-D: The UK’s first fully virtual, commercial, interventional trial for Irritable Bowel Syndrome with Diarrhea (IBS-D).
- PD-STAT: Paving the way for the future of remote trial delivery
- Research register provides rapid access to rare renal disease patients
- New biobank brings a wealth of new opportunities for UK renal research
- Using data to answer to the vitamin D question for dialysis patients
- Novel social media approach to recruit 40,000 volunteers with experience of depression or anxiety
- Rococo: Real-world research in a pharmacy setting
Research-ready NHS workforce
The NIHR is evolving the UK’s research infrastructure to support innovative clinical trials. One of our priorities is to ensure that the NHS workforce has the knowledge and skills required to deliver the next generation of clinical trials.
We have developed an eLearning resource which is freely available to all NHS and NIHR staff (and other organisations on request) via NIHR Learn. If you are not NIHR or NHS and you would like to access this eLearning resource please get in touch using the contact form in the Quick Links section above.
Below you will find a video which provides a taster of this learning resource. We have also created a podcast series which can be accessed via our case study library.
Related Information and funding opportunities
- Life Sciences Industrial Strategy and Sector Deals
The UK Life Sciences Industrial Strategy (August 2017) and the Life Sciences Sector Deal 2 (December 2018) set out the Government’s commitment to consolidate the UK as a world-leader in delivering novel and innovative trials. - Enabling clinicians and researchers to effectively conduct Complex Innovative Design cancer trials
January 2020: A report, published in the British Journal of Cancer, outlines recommendations for the effective delivery of Complex Innovative Design (CID) trials in the UK and Europe. These ten recommendations for cancer trials, made by Experimental Cancer Medicine Centre (ECMC) network which is jointly funded by Cancer Research UK, NIHR, Health and Research Wales, Chief Scientist Office, Public Health Agency - Research and Development).
- NIHR Study Support Service (non-commercial research)
- NIHR Study Support Service for the Life Sciences Industry (commercial research). Access NIHR support to plan, set-up and deliver your study in the NHS or social care environment.
- Studies within a trial (SWAT) funding opportunity and guidance (HTA funding programme)
A related blog on why the funding stream for SWATs is potentially game-changing.
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Remote, decentralised, virtual or hybrid? Clinical trial delivery in the UK is evolving to take trial activities to the patients, rather than using the traditional paradigm of bringing patients to a trial site.
